General uterine manipulator and system

ABSTRACT

A medical instrument configured to be inserted into a body cavity comprises a body comprises a first probe at a first end, the first probe comprising a first cylindrical portion with a first outer circumferential surface of a first diameter; a first circumferential edge at a distal end of the first probe; a first distal lip projecting outwardly from the first outer circumferential surface beyond the first circumferential edge and extending for at least a part of a circumference of the first circumferential edge; and a first marker lip projecting outwardly from the first outer circumferential surface and extending for at least a part of a circumference of the first outer circumferential surface; wherein the first distal lip is positioned distal to the first marker lip; and wherein the body comprises a hollow cavity to enable a second medical instrument to pass therethrough.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT Application No.PCT/US2013/061180, filed Sep. 23, 2013, which is hereby incorporatedherein by reference in its entirety. This applicaion is a Continuationin Part of U.S. application Ser. No. 13/720,086, filed Dec. 19, 2012,which is a Continuation in Part of U.S. application Ser. No. 13/625,255,filed Sep. 24, 2012, which is a Continuation in Part of PCT ApplicationNo. PCT/AU2012/000332, filed Mar. 30, 2012, which claims benefit of U.S.Provisional Application No. 61/472,705, filed Apr. 7, 2011.

BACKGROUND

1. Field

The present disclosure relates to a general uterine manipulator andsystem which may be used in general surgery, gynaecological ornon-surgical procedures.

2. Description

The present inventor has invented numerous medical instruments which arecurrently in use in surgical and non-surgical procedures. One suchinstrument is described in International publication no. WO 2008/074054which is used in various procedures including total laparoscopichysterectomy. The instrument described in this publication comprises atube provided with an integral funnel at one end and through which auterine cannula can be inserted. Both the tube and the cannula areprovided with longitudinal slots or cut outs that aid in visualising therotational position of a distal end of the instrument when inserted intothe vagina and also aid in gripping of the instrument.

The success and efficacy of the above described and other instrumentsdeveloped by the present inventor together with the need for improvedand more versatile instruments have led to the present disclosure.

SUMMARY

According to one aspect of the present disclosure there is provided ageneral uterine manipulator comprising:

an elongated hollow tube defining an internal passage and havingopposite first and second ends;

a smooth continuous outer surface of constant outer diameter extendingbetween the first and second ends; and,

internal first and second screw threads formed in the elongated hollowtube, the first screw thread being formed at the first end and thesecond screw thread being formed at the second end.

The general uterine manipulator may comprise a first fitting having ascrew thread arranged to engage the first screw thread, the firstfitting also having an axial through hole and configured to receive aninner manipulator shaft.

In some embodiments the first fitting is configured to apply increasingclamping force on a received inner manipulator when the first fitting ascrew further into the first end.

The general uterine manipulator may comprise a hydrotubation port influid communication with the internal passage wherein a fluid injectedinto or through the hydrotubation port is able to flow into the internalpassage.

In some embodiments the hydrotubation port is formed in the elongatedhollow tube at a location near the first end and beyond the first screwthread.

In some embodiments the hydrotubation port is formed in the firstfitting and is in fluid communication with the axial through hole.

The axial through hole may comprise a first length which opens onto anend of the first fitting distant the screw thread of the first fitting,and a second contiguous length wherein the first length has a firstinternal diameter and the second length has a second internal diameterwhich is greater than the first internal diameter; and wherein thehydrotubation port opens onto the second length of the axial throughhole.

The general uterine manipulator may comprise a second fitting having athreaded portion provided with a screw thread configured to engage thesecond internal thread on the elongated hollow tube and a body portionextending co-linearly from the threaded portion.

In some embodiments the body portion comprises a tubular member which isopen at one end distal the threaded portion and is closed at an end nearto the threaded portion to form a cavity.

In some embodiments the tubular member comprises a circumferential walland at least one internal passage formed in the circumferential wall,the or each internal passage opening onto axially opposite ends of thecircumferential wall.

In some embodiments the body portion comprises a conically shapedportion with decreasing outer diameter in a taper direction being awayfrom the threaded portion and wherein the conically shaped portion isprovided with an external coarse screw thread.

In some embodiments the second fitting is provided with an axial throughhole.

The general uterine manipulator may comprise an inner manipulator shaft,the shaft capable of being received in the axial through hole of thefirst fitting and the axial through hole of the second fitting andextending through the internal passage.

In some embodiments a crest of the coarse screw thread is provided witha flattened surface wherein a line on the flattened surface is inclinedrelative to a central axis of the coarse screw thread in the taperdirection.

In some embodiments the coarse screw thread is a ball screw thread.

In some embodiments the general uterine manipulator comprising a forcepsholder supported on the elongated hollow tube and configured to bereleasably lockable in a plurality of positions along the elongatedhollow tube.

In some embodiments the forceps holder comprises a first componentseated on the elongated hollow tube and provided with a detent forgripping a finger hole of the forceps.

In some embodiments the forceps holder comprises a locking nut engagablewith the first component and arranged to releasably lock the firstcomponent in a fixed position along the elongated hollow tube whenrotated in a first direction, and to release the second component toallow sliding motion along the elongated hollow tube when rotated in anopposite direction.

In a second aspect there is provided general uterine manipulatorcomprising:

an elongated hollow tube defining an internal passage and havingopposite first and second ends;

a smooth continuous outer surface of constant outer diameter extendingbetween the first and second ends;

internal first and second screw threads formed in the elongated hollowtube, the first screw thread being formed at the first end and thesecond screw thread being formed at the second end;

a first fitting having a screw thread arranged to engage the first screwthread, the first fitting also having an axial through hole;

a second fitting having a threaded portion provided with a screw threadconfigured to engage the second internal thread on the elongated hollowtube and a body portion extending co-linearly from the threaded portion;and,

an inner manipulator shaft arranged to extend through the axial throughhole, the internal passage and the second fitting, the inner manipulatorshaft having one end which is bent and protrudes from the secondfitting.

In one embodiment the general uterine manipulator comprises a resistancemechanism enabling the axial and rotational position of the innermanipulator shaft to substantially held in the absence of adjustment bya user of the manipulator.

In one embodiment the resistance mechanism comprises clamp shellsincorporated in the first fitting.

In one embodiment the resistance mechanism comprises a bend in a portionof the inner manipulator shaft within the internal passage the bendbeing to an extent that the inner manipulator shaft bears against aninside surface of the tube.

In one embodiment the general uterine manipulator comprises ahydrotubation port formed in the first fitting and in fluidcommunication with the axial through hole wherein a fluid injected intoor through the hydrotubation port is able to flow into the internalpassage. In this embodiment the axial through hole comprises a firstlength which opens onto an end of the first fitting distant the screwthread of the first fitting, and a second contiguous length wherein thefirst length has a first internal diameter and the second length has asecond internal diameter which is greater than the first internaldiameter; and the hydrotubation port opens onto the second length of theaxial through hole.

In one embodiment the second fitting comprises a threaded portionprovided with a screw thread configured to engage the second internalthread on the elongated hollow tube and a body portion extendingco-linearly from the threaded portion, the body portion having afrusto-conical shape with decreasing outer diameter in a direction awayfrom the threaded portion and on which is provided an external coarsescrew thread.

In one embodiment the general uterine manipulator comprises a forcepsholder supported on the elongated hollow tube and configured to bereleasably lockable in a plurality of positions along the elongatedhollow tube.

In one embodiment the forceps holder comprises a first component seatedon the elongated hollow tube and provided with a detent for gripping ahandle of the forceps.

In one embodiment the forceps holder comprises a locking nut engagablewith the first component and arranged to releasably lock the firstcomponent in a fixed position along the elongated hollow tube whenrotated in a first direction, and to release the second component toallow sliding motion along the elongated hollow tube when rotated in anopposite direction.

In one embodiment the general uterine manipulator comprises a cervicalfunnel mounted on the tube.

In a third aspect there is provided a general uterine manipulator systemcomprising:

an elongated hollow tube defining an internal passage and havingopposite first and second ends;

a smooth continuous outer surface of constant outer diameter extendingbetween the first and second ends;

internal first and second screw threads formed in the elongated hollowtube, the first screw thread being formed at the first end and thesecond screw thread being formed at the second end;

at least one first fitting the or each first fitting having a screwthread arranged to engage the first screw thread, the first fitting alsohaving an axial through hole;

at least one second fitting the or each second fitting having a threadedportion provided with a screw thread configured to engage the secondinternal thread on the elongated hollow tube and a body portionextending co-linearly from the threaded portion;

wherein the at least one first fitting comprises one or both of: (a) aclamping first fitting configured to apply increasing clamping force ona received inner manipulator when the first fitting a screw further intothe first end; and (b) a hydrotubation first fitting which has ahydrotubation port in fluid communication with the internal passagewherein a fluid injected into or through the hydrotubation port is ableto flow into the internal passage; and wherein the at least one secondfitting comprises one or both of: (c) a cervical second fitting in whichits body portion is of a frusto-conical shape with decreasing outerdiameter in a direction away from the threaded portion and is providedwith an external coarse screw thread; and (d) a tubular second fittingin which its body portion comprises a tubular member which is open atone end distal the threaded portion of the second fitting and is closedat an end near to the threaded portion of the second fitting to form acavity.

In one embodiment the tubular member of the tubular second fittingcomprises a circumferential wall and at least one internal passageformed in the circumferential wall, the or each internal passage openingonto axially opposite ends of the circumferential wall.

In one embodiment the general uterine manipulator system comprises aninner manipulator shaft arranged to extend through the axial throughhole, the internal passage and the second fitting when the secondfitting is the cervical second fitting, the inner manipulator shafthaving one end which is bent and protrudes from the cervical.

In one embodiment the general uterine manipulator system a resistancemechanism enabling the axial and rotational position of the innermanipulator shaft to substantially held in the absence of adjustment bya user.

In one embodiment the general uterine manipulator system a forcepsholder supported on the elongated hollow tube and configured to bereleasably lockable in a plurality of positions along the elongatedhollow tube.

In a fourth aspect there is provided a medical instrument configured tofacilitate a gynaecological procedure comprising:

a body provided with opposite first and second end portions, the firstend portion having a first opening and the second end portion having asecond opening;

a throughway extending between the first and second openings, thethroughway arranged to enable the body to be supported on a shaft tofacilitate insertion of one of the first and second end portions into abody cavity.

In one embodiment the first and second end portions are different in oneor more of their shape, size and configuration.

In one embodiment the first end portion is of a tubular configurationand has a first outer diameter.

In one embodiment the second end portion is of a tubular configurationand has a second outer diameter that is different to the first outerdiameter.

In one embodiment the second end portion is of a frusto conicalconfiguration.

In one embodiment the first end portion is of a frusto conicalconfiguration and has a first outer diameter.

In one embodiment the second end portion is of a frusto conicalconfiguration and has a second outer diameter that is different to thefirst outer diameter.

In one embodiment the or each end portion of frusto conicalconfiguration is provided with a lip that extends radially outward froman outer surface of the second end portion and for an arc of less than360°.

In one embodiment one or both of the first and second end portions isprovided with an illumination device arranged to enable the emission oflight from the respective end portion.

In one embodiment the device comprises an illumination device arrangedto enable the emission of light from the lip.

In one embodiment the general uterine manipulator system comprises anillumination device arranged to enable the emission of light from an endof the tubular portion.

In one embodiment the general uterine manipulator system comprises anillumination device arranged to enable the emission of light from an endof the cervical funnel.

In one embodiment the general uterine manipulator system comprises anillumination device arranged to enable the emission of light from an endof the tubular second fitting.

In one embodiment the general uterine manipulator system comprises amotor arranged to engage and rotate the cervical funnel.

In one embodiment the general uterine manipulator system comprises afoot operated switch associated with the motor and switchable between afirst position wherein the motor rotates in a clockwise direction and asecond position wherein the motor rotates in an anti-clockwisedirection.

In one embodiment the cervical funnel has conical portion and a throughhole formed in or near a large diameter end the conical portion.

In one embodiment the large diameter end of the conical portion has anoutwardly flared lip that extend for a part of the circumference of theconical portion and wherein the hole is formed in the lip.

In one embodiment the general uterine manipulator system comprises anillumination device arranged to illuminate the through hole.

In a fifth aspect there is provided a cervical funnel comprising aconical portion and a through hole formed in or near a large diameterend the conical portion.

In one embodiment the funnel comprises the large diameter end of theconical portion has an outwardly flared lip that extend for a part ofthe circumference of the conical portion and wherein the hole is formedin the lip.

In one embodiment the funnel comprises an illumination device arrangedto illuminate the through hole.

In one embodiment the illumination device comprises an annular lightguide surrounding the through hole.

In a sixth aspect there is provided a cervical funnel comprising aconical portion and a tube extending coaxially form a small diameter endof the conical portion, wherein an outer surface of the tube is profiledto mechanically engage a motor to facilitate rotation of the cervicalfunnel.

In one embodiment the outer surface of the tube is provided with gearteeth arranged to enable mechanical engagement with the motor.

In one embodiment the funnel comprises a through hole formed in or neara large diameter end the conical portion.

In one embodiment the large diameter end of the conical portion has anoutwardly flared lip that extend for a part of the circumference of theconical portion and wherein the hole is formed in the lip.

In a seventh aspect there is provided a double ended medical instrumentarranged for insertion into a body cavity comprising:

a body having a first probe at first end, a second probe at a secondopposite end;

the first probe having a cylindrical portion with an first outercircumferential surface of a first diameter, a first circumferentialedge distant the first end and a first lip projecting outwardly from thefirst outer circumferential surface beyond the first circumferentialedge and extending for at least a part of a circumference of the firstcircumferential edge;

the second probe having a cylindrical portion with a second outercircumferential surface of a second outer diameter, a secondcircumferential edge distant the first probe and a second lip projectingoutwardly from the second outer circumferential surface beyond thesecond circumferential edge and extending for at least a part of acircumference of the second circumferential edge;

wherein the first outer diameter and the second outer diameter aredifferent from each other.

In one embodiment the first and second lips have respective mid-pointsthat are located in axial alignment.

In one embodiment the part of the circumference of the first and secondcircumferential edges about which the first and second lips respectivelyextend are the same.

In one embodiment the first probe is provided with a first cavityextending axially from the first circumferential edge toward the secondprobe and having a first inner diameter.

In one embodiment the second probe is formed with a second cavityextending axially from the second circumferential edge toward the firstprobe and having a second inner diameter wherein the second innerdiameter is different to the first inner diameter.

In one embodiment the first probe is provided with a first platform ofconstant first outer diameter extending over the first cylindricalportion from a circumferential edge of the first lip toward the secondprobe.

In one embodiment the first platform is co-extensive in acircumferential aspect with the first lip.

In one embodiment a side of the first platform rearward of the first lipslopes from the first outer diameter to first outer circumferentialsurface in a direction toward the second probe.

In one embodiment circumferentially opposite sides the first platformtransition smoothly from first outer diameter the first outercircumferential surface.

In one embodiment the second probe is provided with a second platform ofconstant second outer diameter extending over the second cylindricalportion from a circumferential edge of the second lip toward the firstprobe.

In one embodiment the second platform is co-extensive in acircumferential aspect with the second lip.

In one embodiment a side of the second platform rearward of the secondlip slopes from the second outer diameter in a direction toward thefirst probe.

In one embodiment circumferentially opposite sides the second platformtransition smoothly from second outer diameter the second outercircumferential surface.

In one embodiment the platform has a circumferential surface of constantdiameter extending coaxially with the first outer circumferentialsurface.

In one embodiment the double ended medical instrument comprises anintermediate portion that transitions smoothly between the first andsecond probes.

In one embodiment the intermediate portion has a central region of anouter diameter less than each of the first diameter and the second outerdiameter.

In one embodiment the double ended medical instrument comprises anintermediate portion that transitions smoothly between the first andsecond probes wherein the intermediate portion is formed with aninternal bore the bore extending in an axial direction between the firstand second cavities and having an inner diameter smaller than each ofthe first and second inner diameters.

In one embodiment the first lip and second lip extend for the fullcircumference of first circumferential edge and the secondcircumferential edge respectively; the first probe being provided with afirst platform of constant first outer diameter extending wholly aboutthe first cylindrical portion from a circumferential edge of the firstlip toward the second probe; and the second probe being provided with asecond platform of constant second outer diameter extending wholly aboutthe second cylindrical portion from a circumferential edge of the secondlip toward the first probe.

In an eighth aspect there is provided a medical instrument configured tobe inserted into a body cavity, the medical instrument comprising: abody comprising a first probe at a first end, the first probecomprising: a first cylindrical portion with a first outercircumferential surface of a first diameter; a first circumferentialedge at a distal end of the first probe; a first distal lip projectingoutwardly from the first outer circumferential surface beyond the firstcircumferential edge and extending for at least a part of acircumference of the first circumferential edge; and a first marker lipprojecting outwardly from the first outer circumferential surface andextending for at least a part of a circumference of the first outercircumferential surface; wherein the first distal lip is positioneddistal to the first marker lip; and wherein the body comprises a hollowcavity to enable a second medical instrument to pass therethrough.

In some embodiments, the body further comprises: a second probe at asecond end, the second probe comprising: a second cylindrical portionwith a second outer circumferential surface of a second diameter; asecond circumferential edge at a distal end of the second probe; asecond distal lip projecting outwardly from the second outercircumferential surface beyond the second circumferential edge andextending for at least a part of a circumference of the secondcircumferential edge; and a second marker lip projecting outwardly fromthe second outer circumferential surface and extending for at least apart of a circumference of the second outer circumferential surface;wherein the second distal lip is positioned distal to the second markerlip; wherein the second end is opposite the first end; and wherein thefirst diameter and second diameter are different from each other.

In some embodiments, the first marker lip is positioned approximately 20millimeters in a longitudinal direction from the first distal lip.

In some embodiments, the second marker lip is positioned approximately20 millimeters in a longitudinal direction from the second distal lip.

In some embodiments, the first marker lip and first distal lip haverespective mid-points that are located in axial alignment.

In some embodiments, the second marker lip and second distal lip haverespective mid-points that are located in axial alignment.

In some embodiments, the first distal lip and second distal lip haverespective mid-points that are located in axial alignment.

In some embodiments, the medical instrument further comprises apneumatic plug having a tapered surface configured to pneumatically plugat least a portion of the hollow cavity.

In some embodiments, the medical instrument further comprises anintermediate portion that transitions smoothly between the first andsecond probes.

In some embodiments, the medical instrument further comprises anintermediate portion positioned between the first and second probes,wherein the intermediate portion is cylindrical.

In some embodiments, the intermediate portion has a central region of anouter diameter less than each of the first diameter and second diameter.

In a ninth aspect there is provided a double ended medical instrumentconfigured to be inserted into a body cavity, the double ended medicalinstrument comprising: an elongate body comprising: a first cylindricalsegment positioned at a first end of the body; a second cylindricalsegment positioned at a second end of the body; a first plurality ofgraduated cylindrical segments positioned between the first cylindricalsegment and a central cylindrical segment; and a second plurality ofgraduated cylindrical segments positioned between the second cylindricalsegment and the central cylindrical segment; wherein the firstcylindrical segment, second cylindrical segment, and central cylindricalsegment each have different outer diameters, with the centralcylindrical segment having the largest outer diameter; wherein the firstplurality of graduated cylindrical segments comprise outer diameterslarger than the first cylindrical segment, but smaller than the centralcylindrical segment; wherein the second plurality of graduatedcylindrical segments comprise outer diameters larger than the secondcylindrical segment, but smaller than the central cylindrical segment;and wherein the first cylindrical segment, second cylindrical segment,central cylindrical segment, first plurality of graduated cylindricalsegments, and second plurality of graduated cylindrical segments arepositioned collinearly.

In some embodiments, the first cylindrical segment comprises an outerdiameter configured to be smaller than an undilated diameter of a humancervical canal.

In some embodiments, the first cylindrical segment comprises an outerdiameter of approximately two millimeters.

In some embodiments, the second cylindrical segment comprises an outerdiameter larger than any of the first cylindrical segment and the firstplurality of graduated cylindrical segments.

In a tenth aspect there is provided a double ended medical instrumentconfigured to be inserted into a body cavity, the double ended medicalinstrument comprising: a body comprising a probe at a first end, theprobe comprising: a cylindrical plug portion with an outercircumferential surface of a first diameter; a circumferential edge at adistal end of the probe; and a lip projecting outwardly from the outercircumferential surface beyond the circumferential edge and extendingfor at least a part of a circumference of the circumferential edge;wherein the body further comprises a dilator at a second end, the secondend opposite the first end, the dilator comprising: a first cylindricalsegment positioned at a distal end of the dilator; and a plurality ofgraduated cylindrical segments positioned between the first cylindricalsegment and the cylindrical plug portion of the probe, wherein theplurality of graduate cylindrical segments comprise incremental outerdiameters having values larger than an outer diameter of the firstcylindrical segment and smaller than the first diameter of thecylindrical plug portion; wherein the cylindrical plug portion, firstcylindrical segment, and plurality of graduated cylindrical segments arepositioned collinearly.

In some embodiments, the first cylindrical segment comprises an outerdiameter of approximately six millimeters and the first diameter of thecylindrical plug portion is approximately ten millimeters.

In some embodiments, the first diameter of the cylindrical plug portionis of a size configured to pneumatically plug a vaginal canal of youngpig.

In some embodiments, the double ended medical instrument furthercomprises a cylindrical disc configured to support the body, thecylindrical disc comprising: a first port extending from a front surfaceof the disc to a rear surface of the disc, the first port having aninner diameter of a size to enable the body to pass therethrough; and asecond port extending from the front surface of the disc to the rearsurface of the disc, the second port having an inner diameter of a sizeto enable a tail of a pig to pass therethrough to anchor the cylindricaldisc in relation to the pig.

In some embodiments, the cylindrical disc further comprises a hollowtube extending from the front surface of the disc, the hollow tubepositioned collinearly to the first port.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a representation of one embodiment of a general uterinemanipulator in accordance with the present invention;

FIG. 1 b is a disassembled view of the general uterine manipulatordepicted in FIG. 1 a;

FIG. 2 is a longitudinal section view of the tube incorporated in thegeneral uterine manipulator shown in FIGS. 1 a and 1 b;

FIG. 3 is an isometric view of a tail screw incorporated in the generaluterine manipulator shown in FIGS. 1 a and 1 b;

FIG. 4 is a side view of the tail screw shown in FIG. 3;

FIG. 5 is an end view of the tail screw shown in FIG. 3;

FIG. 6 is an isometric view of a second form of tail screw that may beincorporated in the general uterine manipulator shown in FIGS. 1 a and 1b;

FIG. 7 is a side view of the tail screw shown in FIG. 6;

FIG. 8 is an end view of the tail screw shown in FIG. 6;

FIG. 9 a is a side view of a second fitting incorporated in the generaluterine manipulator shown in FIGS. 1 a and 1 b;

FIG. 9 b is a longitudinal section view of the second fitting shown inFIG. 9 a;

FIG. 9 c is an isometric representation of the second fitting;

FIG. 10 a is a side view of a second form of setting fitting that may beincorporated in the general uterine manipulator depicted in FIGS. 1 aand 1 b;

FIG. 10 b is an end view of the second fitting shown in FIG. 9 a;

FIG. 10 c is an isometric view from one end of the second fitting;

FIG. 10 d is a isometric view from an opposite angle of the secondfitting;

FIG. 11 is an isometric view of a forceps holder incorporated in theuterine manipulator;

FIG. 12 is an isometric view of an embodiment of the general uterinemanipulator and associated system with additional fittings to enableperformance of a total laparoscopic hysterectomy; and,

FIG. 13 a is a side view of a cervical funnel incorporated in anembodiment of the general uterine manipulator shown in FIGS. 1 a and 1b;

FIG. 13 b is a longitudinal section view of the cervical funnel;

FIG. 13 c is an end view of the cervical funnel shown in FIGS. 13 a and13 b;

FIG. 14 a is an isometric representation of a vaginal plug incorporatedin an embodiment of the general uterine manipulator shown in FIGS. 1 aand 1 b;

FIG. 14 b is a section view of the vaginal plug shown in FIG. 14 a;

FIG. 15 is a side view of a manipulator handle which may be incorporatedin an embodiment of the general uterine manipulator;

FIG. 16 a is a side view of a further from of second fitting that may beincorporated in the general uterine manipulator depicted in FIGS. 1 aand 1 b;

FIG. 16 b is an end view of the second fitting shown in FIG. 16 a;

FIG. 16 c is an isometric view from a first angle of the second fittingshown in FIG. 16 a;

FIG. 16 d is a isometric view from a second angle of the second fittingshown in FIG. 16 a;

FIG. 16 e is a schematic representation of an illumination deviceincorporated in the second fitting shown in FIG. 16 a;

FIG. 17 a is a side view of a cervical funnel with an illuminationdevice incorporated in a further embodiment of the general uterinemanipulator;

FIG. 17 b is a longitudinal section view of the cervical funnel shown inFIG. 17 a;

FIG. 17 c is an end view of the cervical funnel shown in FIGS. 17 a and17 b

FIG. 17 d is a schematic representation of the illumination deviceincorporated in the cervical funnel shown in FIGS. 17 a and 17 b;

FIG. 18 is an isometric view of the general uterine manipulator shown inFIG. 12 but modified with the inclusion of a drive to enable poweredrotation of an associated cervical funnel;

FIG. 19 is view of cross section A-A of the manipulator shown in FIG.18;

FIG. 20 is a schematic representation of a medical instrument that canbe incorporated in or used with an embodiment of the general uterinemanipulator;

FIG. 21 is a schematic representation of an alternate medical instrumentthat can be incorporated in or used with an embodiment of the generaluterine manipulator;

FIG. 22 is a schematic representation of a further form of medicalinstrument that can be incorporated in or used with an embodiment of thegeneral uterine manipulator;

FIG. 23 a is an isometric view of a double ended medical instrument thatcan be incorporated in or used with an embodiment of a general uterinemanipulator;

FIG. 23 b is a longitudinal section view of the instrument shown in FIG.23 a;

FIG. 23 c is an end view of the instrument shown in FIG. 23 a;

FIG. 24 a is an isometric view of a further double ended medicalinstrument that can be incorporated in or used with an embodiment of ageneral uterine manipulator;

FIG. 24 b is a longitudinal section view of the instrument shown in FIG.24 a;

FIG. 24 c is an end view of the instrument shown in FIG. 24 a;

FIG. 24 d is an enlarged view of an extended probe that can beincorporated in the instrument shown in FIG. 24 a;

FIG. 24 e depicts a cross section of a platform of the probe shown inFIG. 24 a with markings in the form of ridges;

FIG. 24 f depicts a cross section of a platform of the probe shown inFIG. 24 a with markings in the form of grooves;

FIG. 24 g depicts a cross section of a platform of the probe shown inFIG. 24 a with markings in the form of sets of adjacent grooves andridges;

FIG. 25 illustrates a plug that can be used with the instrumentsdepicted in FIGS. 20-24 g;

FIG. 26 illustrates one end of a modified form of the double endedmedical instrument shown in FIG. 24 a having a full circumferenceplatform;

FIG. 27 a is a side view of a further embodiment cervical funnel with anillumination device that may be used with the general uterinemanipulator;

FIG. 27 b is a longitudinal section view of the cervical funnel shown inFIG. 27 a;

FIG. 27 c is an end view of the cervical funnel shown in FIGS. 27 a and27 b; and

FIG. 27 d is a schematic representation of a lip portion of the cervicalfunnel shown in FIGS. 27 a and 27 b.

FIG. 28A illustrates a perspective view of an embodiment of a doubleended medical instrument.

FIG. 28B illustrates a side cross sectional view of the double endedmedical instrument of FIG. 28A.

FIG. 28C illustrates a front view of the double ended medical instrumentof FIG. 28A.

FIG. 29A illustrates a perspective view of an embodiment of a pneumaticplug.

FIG. 29B illustrates a side cross sectional view of the pneumatic plugof FIG. 29A.

FIG. 29C illustrates a front view of the pneumatic plug of FIG. 29A.

FIG. 30A illustrates a perspective view of an embodiment of anotherdouble ended medical instrument.

FIG. 30B illustrates a side cross sectional view of the double endedmedical instrument of FIG. 30A.

FIG. 30C illustrates a front view of the double ended medical instrumentof FIG. 30A.

FIG. 31A illustrates a front view of an embodiment of a medicalinstrument support.

FIG. 31B illustrates a side cross sectional view of the medicalinstrument support of FIG. 31A.

FIG. 32A illustrates a front view of another embodiment of a medicalinstrument support.

FIG. 32B illustrates a side cross sectional view of the medicalinstrument support of FIG. 32A.

FIG. 33A illustrates a front view of another embodiment of a medicalinstrument support.

FIG. 33B illustrates a side cross sectional view of the medicalinstrument support of FIG. 33A.

FIG. 34 illustrates a side view of an embodiment of a cervical dilator.

DETAILED DESCRIPTION

Embodiments of the general uterine manipulator and associated systemprovide a multipurpose manipulator that may be used for a variety ofprocedures by interchanging particular fittings of the manipulator. Withparticular reference to FIGS. 1 a to 2, each embodiment of the generaluterine manipulator 10 (hereinafter referred to in general as“manipulator 10”) is based on or incorporates an elongated hollow tube12 defining an internal passage 14. Tube 12 has opposite first andsecond ends 16 and 18 and a smooth continuous outer surface 20 ofconstant outer diameter. A first internal screw thread T1 is formed atthe first end 16 and a second internal screw thread T2 is formed at thesecond end 18.

The versatility of the manipulator 10 and associated system arises fromthe ability to connect with a number of different fittings depending onthe specific application at hand. FIGS. 1 a and 1 b illustrate a firstfitting in the form of tail screw 22 and a second fitting in the form ofa cervical screw 24. An inner manipulator rod 26 is also illustrated inFIGS. 1 a and 1 b which extends through the first fitting 22, tube 12,and second fitting 24.

One form of the first fitting 22 is shown in greater detail in FIGS. 3to 5. In this embodiment the first fitting 22 comprises a threadedportion 28; an integral body portion 30; and, an internal axial hole 32.Threaded portion 28 is configured to engage screw thread T1 and isprovided with a transverse slot 34 terminating prior to the body portion30. Slot 34 in effect divides the threaded portion 28 into opposed clampshells 36 a and 36 b (hereinafter referred to in general as “clampshells 36”). Body portion 30 is in the general form of a cylinder withtwo flats 38 a and 38 b on opposed sides that assist in gripping of thefitting 22. Axial hole 32 is of constant diameter for the length of thefitting 22 except for a counter sink 40 at a distal end of fitting 22.

Threaded portion 28 is slightly flared outwardly so as it is screwedinto screw thread T1 at end 16, the clamp shells 36 move toward eachother. When an inner manipulator rod 26 is used in the manipulator 10this results in a clamping action on the rod providing resistance tomovement of the rod 26 so as to hold it at a desired rotational andtranslational position. Unscrewing of the portion 28 releases or reducesthis resistance to enable adjustment of the position and orientation ofthe rod 26. Thus the first fitting can be considered in this embodimentas incorporating or comprising a resistance mechanism whichsubstantially maintains the position of the rod 26 until moved oradjusted by a surgeon or other user.

FIGS. 6 to 8 depict an alternate form of the first fitting denoted as22′. Features of the fitting 22′ which are of the same or similarconfiguration or function as those of fitting 22 are denoted with thesame reference numbers but with the addition of the prime (′) symbol.Fitting 22′ comprises a threaded portion 28′, body 30′, an inner axialhole 32′ with counter sink 40′ at a distal end, and opposed flats 38′aand 38′b formed on body portion 30′. Fitting 22′ differs from fitting 22by the omission of slot 34, the inclusion of a hydrotubation port 42,and a re-configuring of the axial hole 32′. With particular reference toFIG. 7 it can be seen that the axial hole 32′ has a first length 44 anda contiguous second length 46. The first length 44 extends from thethreaded portion 28′ for a majority of the axial length of fitting 22′.The second length 46 extends between and joins the counter sink 40′ tothe first length 44. The inner diameter of the first length 44 isgreater than the inner diameter of second length 46′. Further, the innerdiameter of second length 46 is dimensioned to be slightly greater thanan outer diameter of the inner manipulator rod 26 forming a close fitbut enabling the rod 26 to pass through the axial hole 32′.

Hydrotubation port 42 is formed in the body 30′ at a location where itcommunicates with the first length 44. The thread on threaded portion28′ is arranged to engage with the thread T1 at end 16. In the eventthat for example the manipulator 10 is being used in a gynaecologicalapplication and it is desired to inject a liquid such as a dye to assistin the visualisation of tissue the dye may be injected through thehydrotubation port 42. The dye then flows through the internal passage14 and from an opposite end of second fitting 24 attached to end 18. Inthis regard in the event that manipulator rod 26 is in use, a clearanceexists between second fitting 24 and an outer surface of rod 26 to allowthe flow of dye or other fluid. Further, the close fitting between therod 26 and second length 46 of axial hole 32′ substantially prevents anyback leakage of the dye. Alternately and/or in addition if desired, arubber grommet seal (not shown) may be provided in the second length 46to further minimize back leakage of dye or other liquid injected throughthe hydrotubation port 42.

As the fitting 22′ does not have the clamping shells 36 of fitting 22 itis unable to clamp inner manipulation rod 26. However in embodiments ofthe manipulator 10, the inner manipulator rod 26 can be bent to varyingdegrees intermediate of its length so that the rod 26 bears against aninside surface of tube 12 to provide resistance to both axial androtational motion when fitting 22′ is used. This still allows the rod 26to substantially maintain its position until moved or adjustedmanipulated by a surgeon or other user. Thus the intermediate bend inthe rod 26 can be equated with or considered to be another or alternateform of resistance mechanism which substantially maintains the positionof the rod 26 until moved or adjusted by a surgeon or other user.

The second fitting 24 of FIGS. 1 a and 1 b is shown in greater detail inFIGS. 9 a, 9 b and 9 c. The fitting 24 comprises a threaded portion 48configured to engage thread T2, and an integral body portion 50. Bodyportion 50 is of a frusto-conical shape with a decreasing outer diameterin a taper direction D being away from threaded portion 48. A coarsescrew thread 52 is formed about the conically shaped body portion 50.The crest of thread 52 has a flattened surface orientated so that a line53 on the surface of the crest is inclined parallel with a central axis55 of second portion 24. An axial through hole 57 is also formed throughsecond portion 24. This allows for the passage of the inner manipulatorrod 26 and/or other instruments as well as fluids including saline, dye,and air. In this embodiment of the manipulator 10, second fitting 24 isa cervical screw which is configured to screw into the cervix forming anattachment point as well as a seal.

However, alternate forms of second fittings may be incorporated in themanipulator 10. FIGS. 10 a-10 d illustrate an alternate second fitting24 a. Fitting 24 a is in the form of a hollow probe having a threadedportion 48 a and a body portion 50 a. Threaded portion 48 a has a threadconfigured to engage with thread T2. Body portion 50 a is in the form ofa tubular member which is open at its distal end 56 and is closed at anend 58 near threaded portion 48 a to define or otherwise form a cavity60. Distal end 56 is formed with a chamfer or bevel 62 to assist ininsertion of the fitting 24 a into a body cavity such as a vagina orrectum. Fitting 24 a may be used for example during a hysterectomy tomaintain pneumoperitoneum after removal of the uterus. The cavity 60also allows for collection of pelvic tissue and specimens from theabdominal and pelvic cavities. A lumen (i.e. through hole) 64 may beformed axially through a circumferential wall 66 of the body 50 a. Inone embodiment the lumen 64 may have an internal diameter ofapproximately 6 mm to enable the receipt of a 4 mm telescope to enableillumination and visualization of tissue in cavities. For example thismay be used in pelvic floor operations where the vagina and rectumseptum need to be dissected out. This reduces the possibility of arecto-vaginal fistula occurring.

It is envisaged that the fitting 24 a may be made in a variety ofdifferent sizes and in particular different diameters. For example 40 mmouter diameter, 30 mm outer diameter, and 20 mm outer diameter.

FIG. 11 illustrates one form of a forceps holder 70 that may beincorporated in an embodiment of manipulator 10. The forceps holder 70is configured to seat on the elongated hollow tube 12 and releasablylock at a desired location along the tube 12. Forceps holder 70comprises a first component 72 that is able to slide over and along tube12 and is provided with detents 74 for gripping a handle of the forceps.Two detents 74 are shown on opposite sides of a central boss 76. Howeverin other configurations alternate numbers of detent 74 may be provided.The boss 76 is provided with a screw thread 78 extending from a crosspiece 80 which contains the detent 74. Extending axially from the threadportion 78 is a split collar 82. The forceps holder 70 also includes alocking nut 84 that is able to screw onto the threaded portion 78 overthe split collar 82 and act to clamp the collar 82 onto an outer surfaceof the tube 12 thereby releasably locking the holder 70 at an outsidelocation along the tube 12. In one example, the forceps holder 70 may beused to hold vulsellum forceps which in turn holds the manipulator 10 tothe cervix making the manipulator self-retaining.

With reference to FIGS. 12-14 b, the manipulator 10 may also support acervical funnel 90 and a plug 92. The cervical funnel 90 is formed as aunitary device comprising a tube 94 of constant inner and outer diameterand an integral conical portion 96 which increases in outer diameter ina direction away from first end 16 of tube 12. The conical portion isprovided with a lip 98 that extends about a part of the circumference ofconical portion 96 and is flared in a radial outward direction.

Plug 92 sits on the outside of funnel 90 and when used in gynaecologicalprocedures forms a plug in the vagina. With reference to FIG. 12, it canbe seen that the forceps holder 70 may also act as a positioning devicefor the funnel 90.

FIGS. 13 a and 13 b depict in greater detail the cervical funnel 90incorporated in the manipulator 10 shown in FIG. 12. The lip 98 isflared outwardly by an angle θ of approximately 130° but may lay in therange of 130°-160°. In this embodiment the outermost edge of the lip 98extends for an arc α of approximately 115° about the conical portion 96but may lay in the range of about 100°-130°. An inside diameter of thetube 94 is arranged to be slightly greater than the outer diameter ofthe tube 12 to enable the cervical funnel 90 to be rotatably andlinearly moveable with respect to the tube 12.

FIGS. 14 a and 14 b depict in greater detail the vaginal plug 92 shownpreviously in FIG. 12. The plug 92 has a main body 100 formed of aconstant outer diameter and a contiguous distal end portion 102 ofprogressively reducing outer diameter tapering to the distal end 104 ofthe plug 92. When the plug 92 is used with the manipulator 10, it isorientated so that the distal end portion 102 is directed toward thesecond fitting 24. An interior surface 106 of the plug 92 has a firstportion 108 of constant inner diameter, and a contiguous second portion110 of progressively increasing outer diameter. More particularly, thesurface of the portion 110 is arranged to seat an exterior surface ofthe conical portion 96 of cervical funnel 90. Thus the increase in innerdiameter of the surface of portion 110 is substantially the same as theangle of increasing diameter of the outer surface of conical portion 96.

FIG. 15 depicts an optional handle 120 incorporated in embodiments ofthe manipulator 10. The handle 120 comprises a grip 122 and a contiguousextension 124. The extension 124 is provided with a through hole 126 anda screw thread 128. The screw thread 128 extends from approximately thelocation of the hole 126 to an end 130 of the handle 120. The throughhole 126 is dimensioned to enable the tube 12 to pass there througheither with a slight interference fit or a small clearance. Thus thehandle 120 extends perpendicular to the tube 12. The screw thread 130 isconfigured to enable coupling with a nut such as a second locking nut84. The locking nut when tightened on screw thread 128 can then act toclamp the handle 120 to the tube 12. The handle 120 can be applied toany portion of the tube 12 between the end fittings 22 and 24 which isnot otherwise covered by other components such as the cervical funnel90.

From the above description it will be recognised that dependent on theapplication at hand the manipulator may take many different forms owingthe interchangability of first and second fittings and the ability touse additional components such as the rod 26, the forceps holder 70,cervical funnel 90 and the plug 92. It is envisaged that a generaluterine manipulator system or kit may be provided to surgeons anddoctors composed of all or at least a selection of the first and secondfitting; together with other components such as the rod 26, forcepsholder 70, cervical funnel 90 and the plug 92. In this way the surgeonor doctor will always have at hand various components to enable theperformance of many different procedures.

FIGS. 16 a-16 d illustrate a further form of a second fitting 24 b whichprimarily differs from the second fitting 24 a by the inclusion of anillumination device 140. Features of the fitting 24 b that have the samestructure or function as the fitting 24 a are designated with the samereference numbers. In this embodiment the illumination device 140 is inthe form of a ring 142 fitted to or otherwise supported at the distalend 56 of fitting 24 b. The illumination device 140 enables light to beemitted from the distal end 56. In one form the ring 140 is a ring ofmaterial embedded with one or more light emitting diodes (LEDs) 124. Inthis embodiment ring 142 may be made from a transparent acrylic resin.Power to the LEDs 144 is provided via a cable 146 that extends throughthe lumen 64. In the embodiment the lumen 64 may nevertheless beconfigured to also receive a telescope to enable visualization of thebody cavity into which the fitting 24 b is inserted. In a variation ofthe illumination device 140, the ring 142 itself comprises a light guidethat receives light from an optical fiber that passes through the lumen64. Light transmitted through the optical fiber enters and travels aboutthe ring 142 thus enabling the emission of light from the distal end 56.

FIGS. 17 a-17 c depict a cervical funnel 90 a which differs from thecervical funnel 90 by the provision of a light emitting device 140 aenabling the emission of light form distal end 99 and more particularlyfrom the 98 of the funnel 90 a. The funnel 90 a has essentially the samephysical structure as a funnel 90 and accordingly includes a firstconical portion 96 and integrally formed tube 94. The lip 98 extendspartly about an opening 101 formed at the distal end 99. Theillumination device 140 a comprises an arcuate transparent body 142 awhich may for example be made from of a transparent acrylic resin.Coupled to the body 142 a is an optical fiber 146 which is arranged totransmit light from a source to the body 142 a. The body 142 a has aconfiguration enabling it to be attached to the lip 98 in a manner so asto form a substantially continuous surface of the lip 98. The opticalfiber 146 extends can through a channel or hole 148 formed in the funnel90 a. In one embodiment, a channel or groove can be cut in the exteriorsurface of the body 90 a in which the optical fibre 146 is laid.Thereafter the groove can be filled with a resinous material andsmoothed, effectively encapsulating the fiber 146 in the funnel 90 a. Acoupling 148 at the end of the optical fiber 146 enables coupling with alight source or another optical fiber which carries light from the lightsource. In a variation to the illumination device 140 a, the body 142 amay have embedded therein one or more LEDs which when provided withelectric current either: emit light directly from the body 142 a; oralternatively transmit light into the body 122 a from which it isemitted. In the event that the body 122 a carries one or more LEDs, thenthe optical fiber 126 is replaced with a wire or cable to provideelectrical power to the LEDs.

FIG. 18 illustrates a manipulator 10 similar to that shown in FIG. 12but with a modified cervical funnel 90 b and a motor 150 arranged torotate the cervical funnel 90 b on, and relative to, the tube 12. Themotor 150 is held within a housing 152 which is supported on a bracket154. The bracket 154 is a squared U shaped configuration with opposedarms. The motor 150 is attached to one of the arms and a clamp 155attached to the other arm. The clamp 155 can be operated to selectivelygrip and release the tube 12. When the clamp 155 is tightened it gripsthe tube 12 preventing axial or rotational motion of the tube 12.

The cervical funnel 90 b is provided with a wave like outer surfaceprofile on its tube 94 as depicted most clearly in FIG. 19. Successivetroughs 156 and peaks 158 of the wave like profile act as rounded gearteeth about the periphery of tube 94 b. These engage with acomplementary shaped annular gear 160 driven by the motor 150. When themotor 150 is energized it rotates the gear wheel 160 and, due to itsengagement with the outer surface of the tube 94 b, causes the funnel 90b to rotate about and on the tube 12. Due to the manner of engagement ofthe motor 150 with the outer surface of the tube 94, the funnel 90 b canbe slid linearly along the tube 12 while maintaining engagement with themotor 150. The bracket 154 is attached to an arm 162 that in turn can beclamped on to a stable support such as an operating table. A footcontrolled switch 164 communicates with the motor 150 via a cord 166. Asurgeon is able to operate the motor 150 by the foot operated switch164. The motor may be in the forms of a bi-directional stepper motor andthe switch arranged to control the direction of rotation. Theilluminating device 120 a depicted in FIGS. 17 a-17 c may also beincorporated with the funnel 90 b.

FIGS. 20 a-20 c illustrate variations of a medical instrument that maybe used with the manipulator 10. In FIG. 20 the medical instrument 170comprises in effect the second fitting 24 a or 24 b formed back to backand integrally with the cervical funnel 90 or 90 a. The second fittings24 a, 24 b differs slightly from those previously described in that theydoes not comprise a thread portion 48 but rather have a through hole attheir proximal end 172 that communicates with the tube 94. Instrument170 may be considered as comprising a body 174 provided with oppositefirst and second end portions 176 and 178. First end portion 176 has afirst opening 180 and the second end portion 178 has a second opening182. A throughway 184, constitute by the tube 94 extends between thefirst and second openings 180 and 182 and is arranged to enable the body174 to be supported on a shaft such as the tube 12. With reference toFIG. 1 a, if the end of the manipulator 10 provided with the cervicalscrew 24 is taken is the leading end, then the instrument 170 can besupported on the tube 12 with either of the first and second endportions 176, 178 at the leading end of the manipulator 10. Whichever ofthe end portions 176 or 178 is at the leading end will be inserted intothe body cavity during a medical procedure.

In the embodiment in FIG. 20, it can be readily seen that the endportions 176 and 178 differ in one or more of their shape, size andconfiguration. In particular in FIG. 20, the end portions 176 and 178differ in at least their shape and configuration. End portion 176 has anouter diameter D1 measured in a plane of the opening 180 while the endportion 178 has an outer diameter D2 measured in a plane containingopening 162. In this embodiment D1 may equal D2 or alternatively D1 andD2 may be different.

FIG. 21 illustrates an alternate form of medical instrument denoted as170 a comprising an opposite first and second end portions 176 a and 178a respectively joined by an integral tube 94. Each of the portions 176 aand 178 a is of the general configuration of the portion 178 describedin FIG. 20 but with different outer diameters D1 and D2. In particularin this embodiment D1 is less than D2. Instrument 170 a would be used insubstantially the same manner as the second fitting 24 a or 24 b.However having the two end portions of different diameters D1 and D2allows a medical specialist to simply use the end of instrument 170 awhich is dimensioned for the best suit the body cavity into which it isto be inserted.

FIG. 22 illustrates a form of the medical instrument 170 b in which thefirst and second end portions 176 b and 178 b are both of the samegeneral frusto conical configuration as the first end portion 176 inFIG. 20. The difference between the end portion 176 b and 178 b beingtheir respective outer diameters D1 and D2. In this specific embodimentD1 is greater than D2. When the instrument 170 b is used with themanipulator 10 a medical specialist orientates the instrument 170 b withthe end portion 176 b or 178 b at the leading end determined on thebasis of the best match of outer diameter D1 or D2 to the vagina in towhich it is to be inserted.

The instruments 170-170 b may be considered to be double endedinstrument as each of the end portions 176-176 b and 178-178 isconfigured to be inserted in a vagina or rectum. FIGS. 23 a-23 cillustrate a further form of double ended instrument 200 for insertioninto a body cavity. Double ended instrument 200 comprises a body 202having a first probe 204 a and a second probe 204 b (referred to ingeneral as “probe(s) 204”) at one end 206 and an opposite end 208respectively of the body 200. The same reference numbers will be used todenote the same features of each probe. Reference number that includesthe suffix “a” relate to the features of probe 204 a; reference thenumber that includes the suffix “b” relate to the features of probe 204a; and reference numbers with no suffix “a” or “b” refer the feature ingeneral pertaining to either probe 204 a or 204 b.

The first probe 204 a has a cylindrical portion 210 a of a firstcircumferential surface 212 a having an outer diameter Da. Probe 204 ais also provided with a first circumferential edge 214 a at the firstend 206 and a first lip 216 a projecting outwardly from the outercircumferential surface 212 a and beyond the first circumferential edge214 a. The first lip 216 a extends for a part of the circumference ofthe edge 214 a. The lip 216 a may extend for between 100-130° of thecircumference. This is akin to the angle α and the angular extent of thelip 98 shown in FIG. 13 c.

The second probe 204 b has the same general configuration as the probe204 a but with several differences including in dimensions of variousaspects. The probe 204 b has a cylindrical portion 210 b with an outercircumferential surface 212 b having an outer diameter Db. At the end208 the probe 204 b is formed with a second circumferential edge 214 band a second lip 216 b. The second lip 216 b projects outwardly from theouter circumferential surface 212 b and beyond the secondcircumferential edge 214 b.

In this embodiment the diameters Da and Db are different from eachother. In particular Da is >Db. In one example the diameter Da is about40 mm while the diameter Db is about 30 mm. A further difference in thedimensions and configuration of the probes 204 a and 204 b is that thelip 216 b projects at a greater angle θ with respect to itscorresponding adjacent second outer circumferential surface 212 b. As aresult the lip 216 b is inclined at a shallower angle to a centrallongitudinal axis of the instrument 200 than lip 216 a. In a generalsense, each of the lips 216 projects at an angle θ relative to itsadjacent circumferential surface 212 where θ is in the range of130°-160°. This is akin to the angle θ of the lip 98 shown in FIG. 13 b.However in this specific embodiment the angle of projection of the lip216 a is about 140° whereas the angle θb for the lip 216 b is about154°.

A further difference between the probes 204 is the axial difference bywhich each of the lips 216 project in the axial direction. The lip 216 awhich is inclined at a steeper angle than the lip 216 b projects in anaxial direction from a location immediately adjacent the outercircumferential surface 212 a by a length La. The length La is differentto and shorter than the length Lb of axial extent of the lip 216 b. Inone specific example, the distance La may be in the order of 9 mm wherethe distance Lb may be in the order of 13 mm.

Probe 214 a is provided with an internal cavity 220 a of circular crosssection and having an inner diameter 222 a. The outer circumferentialedge 214 a is formed by tapering or flaring the material of the probe204 a at the end 206. The angle of the taper is shown as angle β in FIG.23 b and may lie in a range of 110°-140°. However in this specificembodiment flaring angle β is 130°.

The internal configuration of the probe 204 b is generally the same asthat of probe 204 a but with different dimensions. Specifically, theprobe 204 b has an internal cavity 220 b with an internal diameter 222 bwhich is not the same as and more particularly smaller than the internaldiameter 222 a. In one example the diameter 222 a is about 35 mm and thediameter 222 b is about 35 mm. The probe 204 a at the end 208 is alsotapered to reduce in thickness at an angle βb which is different to andin this embodiment less than the angle βb. In one example, the angle βbmay be 116°.

The probe 200 is formed so that the lips 216 have respectivecircumferential mid points 224 a and 224 b that are in axial alignment.Thus when one probe 204 is inserted into a body cavity with the otherprobe outside of the cavity, a surgeon is able to easily visualize theposition of the lip on the inserted probe by simple reference to theposition of the lip of the non-inserted probe. The arcuate extend of thelips 216, i.e. the angles αa and αb can be arranged to be the either thesame or different. However in this specific embodiment the angle αa>αb.

The double ended probe 200 is also formed with an intermediate portion226 that smoothly transitions between the probes 204 a and 204 b. Theprobe 226 has a central region 228 which is necked and has an outerdiameter less than each of the diameters Da and Db. Thus, the outercircumferential surface 230 of the intermediate portion 226 has aconcave profile. In one example the overall length of the probe 200 isabout 230 mm with each probe 204 having a length of 85 mm and theintermediate portion having a length of 60 mm.

As shown most clearly in FIG. 23 b, the intermediate portion 226 isformed with an internal bore 228 that extends in an axial directionbetween and providing fluid communication with the first and secondcavities 220 a and 220 b. The bore 228 enables the double endedinstrument 200 to be supported on the manipulator 10 and in particularthe hollow tube 12 in the same manner as the funnel 90 and the medicalinstruments 170, 170 a and 170 b.

In a general sense, the double ended medical instrument 200 comprises acombination of the instrument 170 a shown in FIG. 21 but with theaddition of the funnel lips 98 and a reshaping and smoothing of the tube98 and respective adjacent back ends of the portions 176 a and 178 a.

FIGS. 24 a-24 c depict a further embodiment of a double ended medicalinstrument. In this embodiment the double ended medical instrument isdenoted by the reference number 300. The medical instrument 300 is amodified form of the medical instrument 200. All features of the medicalinstrument 300 that are the same as those of the medical instrument 200are denoted with a reference number incremented by 100. For example, theprobes of the medical instrument 300 are denoted by the numbers 304 aand 304 b, the lips are denoted by the reference numbers 316 a and 316 band the intermediate portion is denoted by the reference number 326.Also as with the numbering convention for the instrument 200, referencenumber that includes the suffix “a” relate to the features of probe 304a; reference the number that includes the suffix “b” relate to thefeatures of probe 304 a; and reference numbers with no suffix “a” or “b”refer the feature in general pertaining to either probe 304 a or 304 b.

The double ended medical instrument 300 differs from the double endedmedical instrument 200 solely by the provision of a platform 350 a onthe probe 304 a; and a platform 350 b on the probe 304 b. Platform 350 ahas a constant first outer diameter extending over the cylindricalportion 310 a. More particularly, the platform 350 a has an outercircumferential surface 352 a that is concentric with the outercircumferential surface 310 a but of a greater radius. The platform 350a extends rearwardly from the outer circumferential edge 318 a of thecorresponding lip 314 a. Also in this example the circumferential extentof the platform 350 a is the same as that of the underlying lip 316 a.The platform 350 a extends in an axial direction toward the second probe304 b. Thereafter, the platform smoothly transitions from its rearwardedge 354 a to the circumferential surface 310 a. This transition forms aramp 356 a between the outer circumferential surfaces 352 a and 310 a.Opposite sides 356 a and 358 a of the platform 350 a transition smoothlyto the outer circumferential surface 318 a. Indeed rounded surfaces canbe provided between the outer circumferential surfaces 352 a and thesides 356 a and 358 a.

In this embodiment, the length Pa, that is the axial length of theplatform 350 a is in the order of 20 mm. While this distance may bevaried and in particular extended the significance of the 20 mm lengthwill be described in greater detail below. Suffice to say that it ispossible to increase this length to say 30 or 40 mm and have tactilemarkers for example circumferential ridges or circumferential grooves atvarious set distances or lengths such as 20 mm, 25 mm, 30 mm, 35 mm.

The platform 350 b is of the same general shape and configuration as theplatform 350 a. However the radius of the platform 350 b is different toand in this embodiment smaller than the radius of a platform 350 a.Further, as the lip 314 b is formed with a smaller arc angle αb, thecircumferential width of the platform 350 b is smaller than that ofplatform 350 a. However, the axial length Pb of the platform 350 b inthis embodiment is the same as the length Pa.

Each of the double ended medical instruments 200 and 300 may be used inlaparoscopic gynecological surgery and in particular, for laparoscopichysterectomy. The instrument 200 may be considered as a “standard” modeland the instrument 300 as an “oncology” model.

Each of the medical instruments 200 and 300 can be slid over the uterinemanipulator and in particular the tube 12 as described herein above inrelation to the instruments 170, 170 a and 170 b. Alternatively, themedical instruments 200 and 300, and other medical instruments disclosedherein, can be inserted into a body cavity on their own without theuterine manipulator. In some embodiments, as further described below, aplug is inserted into the medical instrument to pneumatically plug themedical instrument when the medical instrument is inserted into a bodycavity without the uterine manipulator. The specific probe which isinserted is simply dependent upon the size of the cavity at hand. Anadvantage or benefit of the instruments 200 and 300 over say theinstrument 170 b shown in FIG. 22 is that as the probe 204 or 304 is ofa cylindrical shape rather than in the form of a frusto conical funnel,the outer surface 210 can act as a stopper in say the vaginal cavity toprevent leakage of CO₂ gas. Thus the probes 204 may be considered asintegral functional combination of the instrument 170 b shown in FIG. 22together with respective plugs 92. In this way the instrument 200/300can replace the instrument 170 b and respective stops 92 for each of theportions 176 b and 178 b of the instrument 170 b.

The lips 216/316 function as previously described to present the vaginalvault tissue for incision. After a hysterectomy is performed and theuterus is delivered through the vagina, usually an appropriate sizedprobe is inserted to prevent CO₂ leakage. This function is now performedas mentioned before by the provision of the cylindrical probes 204/304.A suture needle can be placed in the cavity 220/320 of the insertedprobe 204 to be picked up by a laparoscopic needle holder tosubsequently suture the vaginal vault.

The instrument 300 by virtue of the provision of the platforms 350 maybe used in oncology procedures relating to cervical cancer. Whencervical cancer is detected in the early stages, common procedure is toremove a 20 mm cuff from the vagina to adequately excise cancer tissue.Usually there is no indicator of how much margin to incise apart fromthe surgeon's subjective perception of adequate cuff removal. Theinstrument 300 provides a platform 350 of known length for example 20 mmto indicate to the surgeon the line of incision to remove an adequatemargin of vaginal cuff. By rotating the lip 314 the vaginal margins arefreed from the bladder anteriorly, the uterine vessels laterally and therectum posteriorly, ensuring that these important structures are clearfrom the vaginal cuff before the vaginal incisions are made. Theprinciples and functions of the instrument 300 is the same as thestandard instrument 200 after the uterus and cervix is removed.

To the best of the Applicant's knowledge there is no vaginal markercolpotomizer available to accurately measure the vaginal margin ofclearance that is required for gynecological oncology cases both inlaparoscopy and open incision or laparotomy surgery. If too much vaginaltissue is removed the shortened vagina will make intercourseuncomfortable. Conversely, inadequate margins will result in cancerrecurrences. Current practice is to gauge the depth of vaginal margin byestimation, and every surgeon has their own estimation method.Embodiments of the instrument 300 provide an accurate measuring tool foradequate vaginal margin removal to ensure the patient has the bestclearance result and the best chance to have a functioning vagina. Theplatforms 350 provide a hard surface to push away the bladder anteriorlyand the rectum posteriorly. The lips 314 ensure adequate uretericdisplacement. The vagina is dissected at the edge of the platform 250.This can be performed in a number of different ways including but notlimited to:

-   -   (a) a knife cutting along the end of the platform 350;    -   (b) cautery or cutting current being applied by a hook electrode        or sharp scissors to the edge of the platform 350;    -   (c) harmonic scalpel energy to incise the vagina at the edge of        the platform 350;    -   (d) a recessed trough at an edge of the platform 350 to guide        vaginal incisions;    -   (e) by providing a hole near an edge of the platform 350 into        which an electrode, monopolar or bipolar is inserted. In this        event by rotating the instrument 300 the vagina is incised by        the energy source being applied.

FIG. 26 depicts one end only of a further embodiment of a double endedmedical instrument 300′ which differs from the instrument 300 by virtueof its platforms 350′ and the lips 314′ that extend for the fullcircumference of the respective probe 304′. (The opposite end of theinstrument 300′ is of the same general configuration as shown in FIG. 26but with the probe 304′ at that end being of a different dimension akinto the differences between probes 204 a and 204 b; or 304 a and 304 b.)The instrument 300′ can be used in laparotomy or open surgery. In thesecases, the platform can be directly palpated hence there is no need torotate the lip 314′/platform 350′ to visualize the margin as inlaparoscopic surgery. By a direct palpitation the vaginal margin isreflected before incisions are made to remove a desired length ofvaginal cuff, for example 20 mm.

As mentioned hereinbefore, the platform of the instrument 300 or 300′used in laparotomy or open surgery can be provided with an axial lengthP greater than say 20 mm with palpatible markings such ascircumferential ridges or grooves at set lengths or distances to providean indication of a precise length of vaginal cuff for incision. This isshown for example in FIGS. 24 d-24 g where markings M1-M4 are providedon the platform 350 at spacings of 20 mm, 25 mm, 30 mm, and 35 mm fromthe outer edge of associated lip 316. In FIG. 24 e the markings M areridges, in FIG. 24 f the markings M are grooves, and in FIG. 24 g themarkings M comprise sets of immediately adjacent circumferential groovesand troughs. The double ended medical instrument with the platform andlip that extend wholly about the respective probes 304 may be termed asthe laparotomy double ended instrument.

In the case of sacrocolpopexy where the bladder and rectum are reflectedback to facilitate placement of mesh on the vagina, the platforms350/350′ in both the oncology and laparotomy double ended medicalinstrument provide a solid dissecting base. However in the event of useof the oncology double ended medical instrument 300 rotation may berequired in order to place the platform 350 in the appropriate location.Clearly no rotation is required for the laparotomy double ended medicalinstrument 300′.

A double ended plug 370 shown in FIG. 25 can be used with the either ofthe standard, oncology or laparotomy double ended medical instrument.The plug has an axially aligned and opposite cylindrical stems 372 of adiameter that provides a light interference fit with the innercircumferential surface at one end of the bore 228,328 of theintermediate portions. Between the stems 372 is a large diametercylindrical portion 374 and an intermediate diameter cylindrical portion376. The portion 374 is dimensioned to form a light interference fitwith the cavity 220 a, or 320 a; and portion 376 is dimensioned to forma light interference fit with the cavity 220 b, 320 b of the probes 204b or 304 b. The plug when fitted into the corresponding end of themedical instrument forms a fluid seal at that end of the seal. Naturallythe plug 370 can only be used when the double ended instrument is notsupported on the manipulator 10. It is envisaged that the plug 300 wouldbe used to assist in maintaining pneumoperitoneum when the double endedinstrument is used without the manipulator 10. In exactly the same waythe plug 370 can be used with any one of the instruments, 170, 170 a and170 b shown in FIGS. 20-22.

In some embodiments, a medical instrument, such as, for example, thevarious double ended medical instruments and cervical funnels describedherein, is configured to maintain pneumoperitoneum without requiring aplug. For example, the medical instruments shown in FIGS. 20-22 maycomprise a solid central section instead of a tube 94 with a throughway184. In such an embodiment, the first opening 180 and second opening 182are not in fluid communication with each other through the centralsection and therefore no plug is required. Further, in such anembodiment, there is no throughway 184, so a tube 12 cannot pass throughthe medical instrument. This may be advantageous for users that do notdesire or require, for example, uterine manipulation, such as with somelaparoscopy or laparotomy.

FIGS. 27 a-27 d illustrate further variations to the cervical funnel 90c. The funnel 90 c is of the same general shape and configuration andworks in the same way as funnel 90, but differs by the provision of athrough hole 190 in the lip 98. The through hole 190 is provided mid wayalong the arc of the lip 98. Optionally the funnel 98 may also comprisean illumination device 192. In this embodiment the illumination device192 is in the form of an annular light guide coupled to an opticalfiber. The annular light guide 192 surrounds the through hole 190. Whenthe optical fiber is coupled to a light source the light is guided bythe fiber 194 to the annular light guide and illuminates the annularlight guide 192 providing a ring of light about the hole 190. Theannular light guide 192 can be in the form a transparent acrylic resinring. The optical fiber 194 can be embedded/encapsulated in a grooveformed along the cervical funnel 90 d.

The hole 190 is dimensioned to receive the tip of an electrical cauteryprobe. During say a hysterectomy the probe is inserted into the hole190. It is believed that the hole 190 will ordinarily be easily visibleor locatable by a surgeon. However the provision of the illuminationdevice 192 will assist in visually locating the hole 190. The electricalcautery probe is inserted through the vagina wall (which is being liftedby the lip 98) and into the hole 190. By applying electric current androtating the funnel 90 d a very clean and precise circumcision can bemade of the vaginal wall to separate it from the cervix.

The through hole 190 may also of course be incorporated in every otherform of cervical funnel described hereinbefore. As can the annular lightguide 192.

FIGS. 28A-28C illustrate a further embodiment of a double endedinstrument 2800. The double ended instrument 2800 is similar in designto the double ended instruments 200 and 300 illustrated in FIGS. 23A-23Cand 24A-24C, respectively. The double ended instrument 2800 comprises afirst probe 2804 a, a second probe 2804 b, and an intermediate portion2826 positioned between the first and second probes. Unlike the doubleended instrument 300, which comprises a generally concave intermediateportion positioned between that double ended instrument's first probeand second probe, the double ended instrument 2800 utilizes a generallycylindrical central region 2828 with generally tapered transitionregions 2829 a and 2829 b positioned at either end.

As with other embodiments of double ended instruments, the first probe2804 a and second probe 2804 b comprise cylindrical portions 2810 a and2810 b which may be utilized, for example, as a plug to maintainpneumoperitoneum. The transition regions 2829 a and 2829 b can beconfigured to have a generally tapered shape to transition between anouter diameter of the central region 2828 and an outer diameter of eachprobe to, for example, enable smooth insertion into and retraction froma body cavity.

The double ended instrument 2800 further comprises a first lip 2816 aand a second lip 2816 b configured to operate similarly to the lips 216a and 216 b of the double ended instrument 200. Namely, the first lip2816 a and second lip 2816 b can be configured to, for example, presentthe vaginal vault tissue for incision. The double ended instrument 2800further comprises a first marker lip 2817 a and a second marker lip 2817b positioned a longitudinal distance 2850 a and 2850 b, respectively,from the first and second lips. In this embodiment, the distances 2850 aand 2850 b are each approximately 20 millimeters. The first and secondmarker lips can be utilized to, for example, act as visual landmarks toindicate where a surgeon should cut. For example, the double endedinstrument 2800 may be utilized in oncology procedures, similar to asdescribed above, to enable a surgeon to easily determine where to cut toremove the cuff from the vagina to adequately excise cancer tissue.

Although in this embodiment, the marker lips 2817 a and 2817 b arepositioned approximately 20 millimeters in an axial or longitudinaldirection away from the first and second lips, in various otherembodiments, the marker lips can be positioned different distances awayfrom the first and second lips to accommodate different lengths ormargins of vaginal cuff to excise. In some embodiments, more than onemarker lip is positioned on each of the probes. For example, multiplemarker lips may be positioned at various distances from the first orsecond lip, similar to the indicators illustrated in FIGS. 24D through24G. Further, in this embodiment, the outer edges of the first markerlip 2817 a, first lip 2816 a, second marker lip 2817 b, and second lip2816 b comprise approximately the same included angle 2860. However, inother embodiments, the outer edges of the marker lips may comprise asmaller or a larger included angle than the first or second lips.Further, although the marker lips in this embodiment are illustrated asbeing rotationally aligned with the first and second lips along acentral axis of the double ended instrument 2800, in other embodiments,the marker lips may be positioned at a different rotational orientationrelative to the first and second lips and/or each other.

The double ended instrument 2800 further comprises a first cavity 2820a, a second cavity 2820 b, and an internal bore 2829. The first andsecond cavities and internal bore can be configured to operate similarlyto the internal cavities and bores of the double ended instruments 200and 300 as further described above.

Pneumatic Plug

FIGS. 29A-29C illustrate an embodiment of a plug 2900. The plug 2900 canbe configured to operate similarly to the plug illustrated in FIG. 25,in that the plug 2900 can be configured to pneumatically plug, forexample, a double ended instrument, such as the double ended instrumentsillustrated in FIGS. 28A-28C, 24A-24C, and 23A-23C. Note that, while theplug 2900 is described in this disclosure in relation to double endedinstruments, such a plug may further be used with various otherembodiments of cervical funnels, colpotomizers, and/or the like.

The plug 2900 comprises a first stem 2908, a second stem 2902, a centralregion 2904, and a tapered region 2906. The second stem 2902, in someembodiments, is configured to be inserted into an internal bore of adouble ended instrument to plug the internal bore to maintainpneumoperitoneum. The plug 2900 would take the place of, for example, ahollow tube 12 as further described above. In this embodiment, thesecond stem 2902 is configured to be generally tapered to easeinstallation into and retraction from an internal bore, such as theinternal bore 2829 illustrated in FIG. 28B. In this embodiment, thesecond stem 2902 comprises an approximately 12 millimeter outer diameterat a distal end and tapers to an approximately 13.8 millimeter outerdiameter at a proximal end where the second stem 2902 meets the centralregion 2904. In some embodiments, as illustrated in FIG. 29B, the plugcomprises a tapered region 2903 between the second stem 2902 and centralregion 2904. In some embodiments, the internal bore 2829 of the doubleended instrument 2800 comprises an inner diameter of approximately 13.1millimeters. Accordingly, the tapered second stem 2902 can be easilyguided into the internal bore 2829 to generate an interference fit withthe internal bore 2829 to enable an airtight or substantially airtightseal.

In some embodiments, the central region 2904 and/or the tapered region2906 can be configured to generate an interference fit with one or morecavities of a double ended instrument to generate an airtight orsubstantially airtight seal. For example, in some embodiments, thesecond cavity 2820 b illustrated in FIG. 28B comprises an approximately25 millimeter inner diameter. Further, the central region 2904 of theplug 2900, in some embodiments, comprises an outer diameter ofapproximately 25 millimeters to enable an interference fit with thesecond cavity 2820 b. In some embodiments, both the second stem 2902 andcentral region 2904 are configured to generate interference fits with adouble ended instrument. In other embodiments, only one or the other isconfigured to generate an interference fit with a double endedinstrument.

In some embodiments, the first stem 2908 can also be configured togenerate an interference fit with, for example, an internal bore of adouble ended instrument. In other embodiments, the first stem 2908 canbe configured to operate merely as a handle to ease insertion andretraction of the plug 2900. In some embodiments, the tapered region2906 can also or alternatively be configured to form an interference fitwith an internal bore or cavity of a double ended instrument.

Pig Colpotomizer

FIGS. 30A-30C illustrate a double ended medical instrument or pigcolpotomizer 3000. The double ended medical instrument 3000 has somefeatures in common with the various medical instruments described abovefor use in, for example, laparoscopic hysterectomies. However, thedouble ended instrument 3000 is configured to be used with a pig, ratherthan a human.

When surgeons are training for laparoscopic surgery, the surgeons oftenuse an animal model to teach laparoscopic techniques which involveincisions, dissections, energy use, and suturing. Various organs in ananimal model are deliberately incised or removed to simulate events inthe human patient. In the case of laparoscopic abdominal or vaginalsurgery, piglets are typically weaned at four weeks old and then fed foranother two weeks so that they weigh approximately 30 kilograms. Theirabdominal cavities then sufficiently simulate a human and are suitableto be used for laparoscopic surgery training. The piglets' reproductiveorgans, however, especially the vagina, are typically not fullydeveloped in size at this point. This is because female pigs typicallybreed at nine months, when they are sexually mature and weightapproximately 120 kilograms.

Performing a total laparoscopic hysterectomy (TLH) using pigs ischallenging anatomically due to, among other things, differing anatomyof the reproductive organs and small organ size, especially with thevagina, due to the relatively young age of the animals used.Accordingly, performing a successful TLH on a piglet has historicallybeen a difficult task.

The pig colpotomizer or double ended instrument 3000 illustrated inFIGS. 30A-30C is configured to enable a surgeon to successfully performa TLH on a young pig. A typical piglet's vagina is approximately 100millimeters to 140 millimeters long. At the end of the vagina, an innersleeve of cervix is attached. The cervix is connected to a short centralbody from which two uterine horns arise. In these horns, future pigletsdevelop. At the end of each uterine horn there is an ovary and fallopiantube. Past hysterectomy workshops on a pig have involved resection ofthe central cervical body where the two uterine horns meet, not thevaginal-cervical junction as in a true TLH. Additionally, resection atthe vaginal-cervical junction involves securing the uterine vesselseither by energy or ligating, a step that most closely simulates TLH inthe human. The technique of vaginal-cervical resection is not possiblewithout a colpotomizer, such as, for example, the double ended medicalinstrument 3000, to accurately outline and delineate this anatomicallandmark.

The double ended instrument 3000 comprises a colpotomizer portion 3004and a dilator portion 3002. The instrument 3000 comprises generally anelongated cylindrical tool having the dilator portion 3002 onapproximately one-half of the device and the colpotomizer portion 3004on the other half. In some embodiments, an overall length of theinstrument 3000 is approximately 250 millimeters. However, in otherembodiments, the overall length and the length of each portion can vary.

The dilator portion 3002 is configured to gently dilate a pig's vaginaby utilizing multiple graduated regions 3008. The dilator portion 3002begins with a first end 3007 having a first outer diameter. The multiplegraduated regions 3008 increase in diameter until the dilator portion3002 meets the colpotomizer portion 3004, which has a cylindricalportion 3010 of a larger diameter than the nearest graduated region 3008of the dilator portion 3002. In some embodiments, the graduated dilatorcommences at six millimeters outer diameter and increases to tenmillimeters outer diameter in one millimeter increments. For example,the first end 3007 may be approximately six millimeters in outerdiameter, while the cylindrical portion 3010 is approximately tenmillimeters in outer diameter, with each graduated region 3008comprising a diameter between six and ten millimeters.

In some embodiments, the cylindrical portion 3010 comprises an overalllength of approximately 120 to 140 millimeters. The cylindrical portion3010 comprises at one end an asymmetrical funnel or lip 3016. The lip3016 can be configured to operate similarly to the lips illustrated invarious other embodiments as described herein. The included angle 3060of the lip 3016 can vary, as with other embodiments.

In use, the double ended instrument 3000 is operated by first insertingthe dilator portion 3002 into the pig's vagina to dilate the vagina.Then, the double ended instrument 3000 is extracted, and thecolpotomizer portion or asymmetrical funnel end is inserted and advancedto the end of the cervical canal. Similar to with the othercervical/vaginal funnels as further described above, when thecolpotomizer is rotated, the asymmetrical end with the raised lip 3016is configured to raise the vaginal vault (the junction between thecervix and the vagina) to, for example, indicate placement of thevaginal incision to the surgeon. After incision of the vagina to freethe cervix, the cervix, uterus, ovaries, and tubes, which have beendissected prior to the vaginal incision technique, can be placed intothe vaginal canal by gently pulling out the colpotomizer 3000. Afterextraction of the tissue, the colpotomizer 3000 can be inserted backinto the vagina to prevent CO₂ leakage while the vaginal vault openingis closed by sutures. For example, the cylindrical portion 3010 can beconfigured to form an airtight or substantially airtight seal with thevaginal tissue.

In this embodiment, the colpotomizer 3000 is a solid device, unlike thehollow embodiments further described above as used with humans. Onereason for this is that, in human operations, uterine manipulation isoften required. However, in pig hysterectomy operations, uterinemanipulation is often not required.

In some embodiments, the pig colpotomizer 3000 can be held in place inthe pig's vagina by a person. In other embodiments, a medical instrumentsupport is utilized to hold the medical instrument in position in thepig's vagina. For example, embodiments of such medical instrumentsupports can be seen in FIGS. 31A-31B, 32A-32B, and 33A-33B. FIGS. 31Aand 31B illustrate an embodiment of a medical instrument support 3100.The medical instrument support 3100 comprises a generally circular dischaving an outer diameter 3102 of approximately 60 millimeters to 80millimeters, and a width 3104 of approximately ten millimeters. Notethat, although the medical instrument support 3100 and other medicalinstrument supports described in this disclosure generally comprise acircular disc shape, various other shapes and sizes may be utilized aslong as the medical instrument support adequately performs the functionsas described herein with respect to supporting, for example, a pigcolpotomizer.

The medical instrument support 3100 comprises a medical instrument port3106 and an appendage port 3108. The medical instrument port 3106 can beconfigured to enable insertion of a medical instrument therethrough, forexample, the pig colpotomizer 3000 illustrated in FIGS. 30A-30C, toenable support of the medical instrument and/or rotation of the medicalinstrument while inserted into the pig's vagina. In some embodiments,the medical instrument port 3106 can comprise an inner diameter ofapproximately 15 millimeters to 20 millimeters.

The appendage port 3108 can be configured to enable an appendage of asubject being operated on to be passed therethrough to anchor themedical instrument support 3100. For example, in this embodiment, theappendage port 3108 is configured to enable a surgeon to pass a pig'stail therethrough to anchor the medical instrument support 3100. In someembodiments, the tail is secured to the medical instrument support 3100by placing a suture through the tail and passing the tail through theappendage port 3108, and optionally repeating that procedure one or moretimes until the tail is anchored securely. When an appendage is anchoredto the medical instrument support 3100, this enables stabilization ofthe colpotomizer, while still allowing rotation of the colpotomizerwithin the medical instrument port 3106.

FIGS. 32A-32B and FIGS. 33A-33B illustrate further embodiments ofmedical instrument supports. The medical instrument support 3200illustrated in FIGS. 32A and 32B is configured to operate similarly tothe medical instrument support 3100, except the medical instrumentsupport 3200 further comprises a sleeve 3210. The sleeve 3210 comprisesa generally cylindrical tube extending from a face of the medicalinstrument support 3200 generally parallel to a central axis of themedical instrument port 3106. The sleeve 3210 can be configured toprovide additional surface area for the support and stabilization of amedical instrument passing therethrough.

FIGS. 33A and 33B illustrate a further embodiment of a medicalinstrument support 3300. The medical instrument support 3300 isconfigured to operate similarly to the medical instrument support 3200.However, the medical instrument support 3300 utilizes a medicalinstrument port 3306 comprising a blind hole within the sleeve 3310,rather than being a through hole as with the embodiments illustrated inFIGS. 31A-31B and 32A-32B. In this embodiment, the medical instrumentport 3306 is still configured to support a medical instrument, such as apig colpotomizer, except the medical instrument can only be inserted upto the depth of the blind hole comprising the medical instrument port3306.

Cervical Dilator

FIG. 34 illustrates a cervical dilator 3400 that can be utilized todilate, for example, a human cervical canal. The cervical dilator 3400comprises a first end 3402, a second end 3404, a central region 3406,and a plurality of graduated regions 3408 positioned between the firstend 3402, the central region 3406, and the second end 3404. The cervicaldilator 3400 can be configured to utilize the concepts illustrated bythe dilator portion 3002 of the pig colpotomizer 3000 illustrated inFIGS. 30A-30C. Namely, the cervical dilator 3400 can be configured togradually dilate a human or other animal cervical canal to enable theinsertion of instruments to, for example, sample the uterus or to enableinsertion of a hysteroscope to visualize the uterus. A typical uterinecavity length is approximately 70 millimeters to 80 millimeters.Accordingly, the overall length of the dilator 3400 and/or the length ofeach of its segments can be configured to accommodate various uterinelengths.

In use, the cervical dilator 3400 can be inserted into the vaginalcanal, with the second end 3404 leading the dilator into the canal. Thecervical canal can then be dilated gradually by further inserting thecervical dilator 3400 to enable the graduated regions 3408 of increasingdiameter to gradually increase the dilation of the cervical canal. Insome embodiments, only one end or half of the cervical dilator 3400 isutilized. For example, either the second end 3404 or the first end 3402is inserted into the vaginal canal. Which end is inserted into thevaginal canal may depend upon, for example, the undilated diameter ofthe cervical canal. In some embodiments, both ends or halves are used todilate a cervical canal. For example, the second end 3404 and itsadjacent graduated regions 3408 can be inserted into the cervical canalto begin the dilation. Then, the cervical dilator 3400 can be extractedand flipped, and the first end 3402, along with its adjacent graduatedregions 3408, can be inserted to complete the dilation up to potentiallythe largest diameter of the cervical dilator 3400, shown here in thecentral region 3406.

In some embodiments, one end or both ends of a cervical dilator cancommence at two or three millimeters in diameter and gradually increase,at longitudinal distances from five millimeters to 20 millimeters, toouter diameters of any dimension within the limits of the overall outerdiameter of the dilator. In some embodiments, one end of the dilatorcommences at the largest outer diameter of the opposite end. Forexample, referring to the cervical dilator 3400, in some embodiments,the first end 3402 may be configured to be approximately the same outerdiameter as the largest graduated region 3408 of the opposite end of thecervical dilator 3400.

Cervical dilators as described herein can be advantageous for use ingynecological procedures. Such a one piece dilator can be easier to usethan other potential solutions, such as dilators that compriseindividual dilator rods each having a fixed outer diameter. Such rodsmay, for example, begin at two millimeters and progress to 20millimeters or any other desired outer diameter, with a different rodbeing used for each diameter. If such dilator rods are used, a surgeonmust insert and remove a plurality of dilator rods before the surgeon isable to get the cervical canal to the proper dilation. However,utilizing a cervical dilator such as the cervical dilator 3400 describedherein, a surgeon can use a single tool to easily and quickly dilate thecervix. Further, a cervical dilator as described herein can moregradually dilate the cervix by incorporating a plurality of graduatedregions 3408. When using dilator rods having fixed outer diameters, asurgeon may be tempted to use a smaller number of rods, and will not asgradually dilate the cervical canal. Accordingly, it can be seen that acervical dilator such as the cervical dilator 3400 shown in FIG. 34 hasseveral advantages over dilator rods of fixed outer diameter.

Now that an embodiment of the invention has been described in detail itwill be apparent to those skilled in the relevant arts that numerousmodifications and variations may be made without departing from thebasic inventive concepts. For example, in one embodiment, thehydrotubation port 42 is illustrated and described as being formed onthe first fitting 22. However in an alternate embodiment, ahydrotubation port may be formed on the tube 12 at a location near firstend 16 but beyond the screw thread T1. In one embodiment, the first andsecond fittings 22, 24 may be formed from a plastics material so as tobe disposable after a single use while the elongated hollow tube 12 maybe made from surgical grade stainless steel so as to be reusable. Alsoas would be readily apparent to one of ordinary skill further doubleended instruments may be constructed using combinations end portions orprobes shown in FIGS. 20-26 of the same or different size. For example adouble ended instrument could comprise: a probe 204 a at one end and aprobe 304 a at another, where the probes are of the same or differentouter diameter; a probe 204 a at one end and a probe 304′a at another,where the probes are of the same or different outer diameter; an endportion 176 a at one end and a probe 204 b at the other, where theprobes are of the same or different outer diameter; etc. All othercombinations of the currently disclosed probes and end portions arepossible. All such modifications and variations together with othersthat would be obvious to persons of ordinary skill in the art are deemedto be within the scope of the present invention the nature of which isto be determined from the above description and the appended claims.

What is claimed is:
 1. A medical instrument configured to be insertedinto a body cavity, the medical instrument comprising: a body comprisinga first probe at a distal end and a second probe at a proximal end, thefirst probe comprising: a first cylindrical portion with a first outercircumferential surface of a first diameter; a first lip projectingoutwardly from the first outer circumferential surface, extendinglongitudinally beyond an outer end of the first cylindrical portion, andextending circumferentially about only a portion of the first outercircumferential surface; and a second lip projecting outwardly from thefirst outer circumferential surface, extending circumferentially aboutonly a portion of the first outer circumferential surface, and extendingcircumferentially about the first outer circumferential surface throughan arc that subtends an angle of at least 100 degrees; wherein the firstlip is positioned distal to the second lip to raise vaginal tissue toprovide a visual landmark at a location distal to the second lip;wherein the first lip and second lip have respective mid-points that arelocated in axial alignment; wherein the body comprises a first hollowcavity to enable a medical device to pass therethrough; wherein thesecond probe comprises: a second cylindrical portion with a second outercircumferential surface of a second diameter; a third lip projectingoutwardly from the second outer circumferential surface, extendinglongitudinally beyond an outer end of the second cylindrical portion,and extending circumferentially about only a portion of the second outercircumferential surface; and a fourth lip projecting outwardly from thesecond outer circumferential surface, extending circumferentially aboutonly a portion of the second outer circumferential surface; andextending circumferentially about the second outer circumferentialsurface through an arc that subtends an angle of at least 100 degrees;wherein the third lip is positioned proximal to the fourth lip; andwherein the first diameter and second diameter are different from eachother.
 2. The medical instrument of claim 1, wherein the second lip ispositioned approximately 20 millimeters in a longitudinal direction fromthe first lip.
 3. The medical instrument of claim 1, wherein the fourthlip is positioned approximately 20 millimeters in a longitudinaldirection from the third lip.
 4. The medical instrument of claim 1,wherein sides of the second maker lip transition smoothly from the firstouter circumferential surface to limit damage to body tissue when themedical instrument is rotated within the body cavity.
 5. The medicalinstrument of claim 1, further comprising a pneumatic plug having atapered surface configured to pneumatically plug at least a portion ofthe first hollow cavity.
 6. The medical instrument of claim 1, whereinthe first probe comprises a second hollow cavity comprising a sizesufficient to fit around a human cervix, enabling the first lip toprovide a visual landmark for vaginal tissue as the medical instrumentis rotated, the second hollow cavity positioned distally to the firsthollow cavity, the second hollow cavity being larger in a transversedirection than the first hollow cavity.
 7. The medical instrument ofclaim 1, further comprising an intermediate portion that transitionssmoothly between the first and second probes, the intermediate portioncomprising a central region having an outer diameter less than each ofthe first diameter and second diameter.
 8. The medical instrument ofclaim 1, further comprising an intermediate portion positioned betweenthe first and second probes, wherein the intermediate portion iscylindrical, the intermediate portion comprising a central region havingan outer diameter less than each of the first diameter and seconddiameter.
 9. The medical instrument of claim 1, wherein an outer edge ofthe first lip is concentric with the first outer circumferentialsurface.
 10. The medical instrument of claim 1, wherein an outer edge ofthe second lip is concentric with the first outer circumferentialsurface.
 11. The medical instrument of claim 1, wherein the second lipcomprises a tapered shape that is wider adjacent the first outercircumferential surface than at an outer edge of the second lip.
 12. Themedical instrument of claim 1, wherein the body comprises a surgicalgrade material.
 13. The medical instrument of claim 1, wherein the firstprobe comprises a length of approximately 85 millimeters.
 14. Themedical instrument of claim 1, wherein the first diameter of the firstouter circumferential surface is approximately 40 millimeters.
 15. Themedical instrument of claim 1, wherein the first diameter of the firstouter circumferential surface is approximately 40 millimeters, and thesecond diameter of the second outer circumferential surface isapproximately 30 millimeters.
 16. The medical instrument of claim 1,wherein the first lip is flared outwardly from the first outercircumferential surface by an angle in the range of 130 to 160 degrees.17. A method of using the medical instrument of claim 1 to perform anoncology procedure, the method comprising: inserting the first probe ofthe body of the medical instrument into a vaginal cavity; positioningthe second lip of the first probe to act as a visual landmark thatindicates where a surgeon should cut to remove a cuff from the vagina toexcise cancer tissue; cutting vaginal tissue to remove the cuff; andremoving the first probe of the body of the medical instrument from thevaginal cavity.